Evidence map›Paper›PMID 36259527›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023

Limited Weight Impact After Switching From Boosted Protease Inhibitors to Dolutegravir in Persons With Human Immunodeficiency Virus With High Cardiovascular Risk: A Post Hoc Analysis of the 96-Week NEAT-022 Randomized Trial.

Laura Waters, Lambert Assoumou, Ana González-Cordón, Stefano Rusconi, Pere Domingo, Mark Gompels, Stephane de Wit, François Raffi, Christoph Stephan, Mar Masiá and 14 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02098837 (An Open Label Study Examining the Efficacy and Cardiovascular Risk of Immediate Versus Deferred Switch From a Boosted PI to Dolutegravir), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
3.6field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02098837 phase4completednot on this map

An Open Label Study Examining the Efficacy and Cardiovascular Risk of Immediate Versus Deferred Switch From a Boosted PI to Dolutegravir (DTG) in HIV Infected Patients With Stable Virological Suppression

TypeinterventionalSponsorSt Stephens Aids TrustRan2014 to 2017Enrolled415ConditionsHIVArmsDolutegravir
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 20 institutions in 6 countries.

Laura WatersMortimer Market Centre, Central and North West London National Health Service (NHS) Foundation Trust, London, United Kingdom.
Lambert AssoumouSorbonne Université, Inserm, Institut Pierre Louis d'Épidémiologie et de Santé Publique, Paris, France.
Ana González-CordónHospital Clínic, Consorci Institut D'Investigacions Biomediques August Pi i Sunyer, Universitat de Barcelona.
Stefano RusconiUnità Operativa Malattie Infettive, Ospedale Civile di Legnano, Azienda Socio Sanitaria Territoriale Ovest Milanese, Legnano (MI), Italy.
Pere DomingoCentro de Investigación Biomédica en Red de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid, Spain.
Mark GompelsNorth Bristol NHS Trust, Bristol, United Kingdom.
Stephane de WitCentre Hospitalier Universitaire Saint-Pierre, Brussels, Belgium.
François RaffiCentre Hospitalier Universitaire, Nantes, France.
Christoph StephanUniversitätsklinikum, Goethe-University, Abteilung für Infektionskrankheiten, Frankfurt, Germany.
Mar MasiáCentro de Investigación Biomédica en Red de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid, Spain.
Jürgen RockstrohUniversitätsklinikum, Bonn, Germany.
Christine KatlamaHôpital Universitaire Pitié Salpêtrière, Paris, France.
Georg M N BehrensMedizinische Hochschule, Hannover, Germany.
Graeme MoyleChelsea and Westminster Hospital NHS Foundation Trust.
Margaret JohnsonRoyal Free London NHS Foundation Trust.
Julie FoxGuy's and St Thomas' NHS Foundation Trust/King's College, London, United Kingdom.
Hans-Jürgen StellbrinkInfektionsmedizinisches Centrum, Hamburg, Germany.
Giovanni GuaraldiUniversità degli Studi di Modena e Reggio Emilia, Modena, Italy.
Eric FlorenceInstituut voor Tropische Geneeskunde, Antwerp, Belgium.
Stefan EsserUniversitätsklinikum, Essen, Germany.
José M GatellViiV Healthcare, Barcelona, Spain.
Anton PozniakChelsea and Westminster Hospital NHS Foundation Trust.
Esteban MartínezHospital Clínic, Consorci Institut D'Investigacions Biomediques August Pi i Sunyer, Universitat de Barcelona.
NEAT 022 Study Group
Instituto de Salud Carlos III · ESUniversity Hospital Bonn · DECentro de Investigación Biomédica en Red · ESNorth Bristol NHS Trust · GBAzienda Ospedaliera Ospedale Civile di Legnano · ITCentre Hospitalier Universitaire de Nantes · FRChelsea and Westminster Hospital NHS Foundation Trust · GBEssen University Hospital · DEInfektionsmedizinisches Centrum Hamburg · DEMedizinische Hochschule Hannover · DERoyal Free London NHS Foundation Trust · GBSorbonne Université · FRUniversity of Modena and Reggio Emilia · ITCentral and North West London NHS Foundation Trust · GBCentre Hospitalier Universitaire de Saint-Pierre · BEGoethe University Frankfurt · DEInstituut voor Tropische Geneeskunde · BEKing's College London · GBNational Health Service · GBViiV Healthcare (Spain) · ES

Funding

Medical Research Council MC_UU_00004/03Medical Research Council MC_UU_12023/2Medical Research Council MC_UU_12023/23
6 · The paper itself

Abstract

backgroundIn the NEAT022 trial, virologically suppressed persons with human immunodeficiency virus (HIV) at high cardiovascular risk switching from protease inhibitors to dolutegravir either immediately (DTG-I) or after 48 weeks (DTG-D) showed noninferior virological suppression and significant lipid and cardiovascular disease risk reductions on switching to dolutegravir relative to continuing protease inhibitors.

methodsIn post hoc analysis, major endpoints were 48-week and 96-week weight and body mass index (BMI) changes. Factors associated with weight/BMI changes within the first 48 weeks of DTG exposure, proportion of participants by category of percentage weight change, proportions of BMI categories over time, and impact on metabolic outcomes were also assessed.

resultsBetween May 2014 and November 2015, 204 (DTG-I) and 208 (DTG-D) participants were included. Weight significantly increased (mean, +0.810 kg DTG-I arm, and +0.979 kg DTG-D arm) in the first 48 weeks postswitch, but remained stable from 48 to 96 weeks in DTG-I arm. Switching from darunavir, White race, total to high-density lipoprotein cholesterol ratio <3.7, and normal/underweight BMI were independently associated with higher weight/BMI gains. The proportion of participants with ≥5% weight change increased similarly in both arms over time. The proportions of BMI categories, use of lipid-lowering drugs, diabetes and/or use of antidiabetic agents, and hypertension and/or use of antihypertensive agents did not change within or between arms at 48 and 96 weeks.

conclusionsSwitching from protease inhibitors to dolutegravir in persons with HIV with high cardiovascular risk led to modest weight gain limited to the first 48 weeks, which involved preferentially normal-weight or underweight persons and was not associated with negative metabolic outcomes. CLINICAL TRIALS REGISTRATION: NCT02098837 and EudraCT 2013-003704-39.

Indexed as

Anti-HIV AgentsCardiovascular DiseasesHIV-1HIV InfectionsDolutegravirHeart Disease Risk FactorsHeterocyclic Compounds, 3-RingHumansLipidsProtease InhibitorsRisk FactorsThinnessTreatment OutcomeAnti-HIV AgentsDolutegravirHeterocyclic Compounds, 3-RingLipidsProtease Inhibitorsdolutegravirswitchweight

Identifiers

PMID36259527
PMCPMC7617433
OpenAlexW4306784225

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.